Job Title: Regulatory Affairs Manager - IVDs
Job Type: Maternity Cover – 12 Month Contract
Location: West London, UK – Hybrid/Remote
Salary: £60,000 - £76,000
Cpl Life Sciences is partnering with a global leading biotechnology business at the heart of innovation.
This role is sitting at the interface of therapeutics and diagnostics, helping bring biomarker-driven medicines to market through companion diagnostic and IVD regulatory strategy.
The Temporary Manager, Regulatory Affairs IVD will provide project management support for performance studies applications and performance study notifications.
This role will partner with clinical study teams, site start-up teams, and performance study sponsors to facilitate on-time clinical trials.
The temporary Manager, Regulatory Affairs IVD will be responsible for planning, coordinating, tracking and driving execution of performance study applications and performance study notifications activities in accordance with EU IVDR.
Essential Functions required for the job
- Lead operational planning of IVD performance study notifications/applications activities.
- Coordinate cross-functional activities required for performance study notifications/applications milestones, trackers, requests for information, and risk mitigation plans.
- Ensure timely responses to regulatory authority requests for information.
- Facilitate communication between performance study sponsors, clinical study teams and regulatory stakeholders.
- Track country-specific submission requirements and maintain submission status trackers.
- Contribute to continuous improvement focused on submission planning, tracking and operational efficiency
Job Requirements
Minimal Requirements
Bachelor's degree in Life Sciences, Engineering or a related technical field
5+ years’ pharmaceutical or diagnostics industry experience, including 1-2 years IVD/Medical Device Regulatory Affairs experience.
Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA)
Familiarity with international IVD regulations (IVDR, PMDA, etc.) and global registrational processes for medical devices/IVDs
Excellent written and verbal communication skills
Preferred Requirements
- Advanced degree (Master's and above).
- Experience with companion diagnostic development processes and regulatory filings
Please note this role is a contract role paying a fixed salary and requires someone to be based in the UK or Ireland.
You must be comfortable with hybrid working and be on no more than a 4-week notice period.